Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Close this folder1. National drug regulation
Close this folderGuiding principles for small national drug regulatory authorities1,2
Close this folder1. General considerations
View the document1.1 The scope of drug control
View the document1.2 Basic responsibilities
View the document1.3 Licensing functions
View the document1.4 Product licences
View the document1.5 Manufacturers’ and distributors’ licences
View the document1.6 New drug assessments
View the document1.7 Authorization of clinical trials
View the document1.8 Terms of reference of the regulatory authority
View the document1.9 Powers of enforcement
View the document1.10 Technical competence
View the document1.11 Advisory bodies
View the document1.12 Independence of operation
Open this folder and view contents2. Administrative aspects of the licensing process
Open this folder and view contents3. Technical aspects of the licensing process
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
1.8 Terms of reference of the regulatory authority

The formal terms of reference of a national drug regulatory authority are determined by statute and regulation. Legislation relating to pharmaceutical products has developed piecemeal in many countries, and there are obvious advantages in bringing matters concerned with their regulation under one law. For example, it is important to correlate laws relating to the control of narcotic and psychotropic substances with requirements for product registration. If comprehensive overhaul of the legal system is impracticable, control within the existing framework through regulations specifically related to the registration of pharmaceutical products offers advantages of economy and time-saving. Whichever option is chosen, regulatory authorities require the flexibility to respond to changing circumstances imposed by the evolution of pharmaceutical science. In general terms, the authority should be vested with legal powers to:

(a) issue, vary and revoke licences for pharmaceutical products on grounds of quality, safety, and efficacy;

(b) secure the subsequent safe and effective use of each product by controlling, through the terms of the licence, the content of all labelling (including package inserts, associated prescribing information and advertising) and the channels through which the product may legitimately be supplied; and

(c) inspect and license all manufacturing premises, importing agents, wholesalers and distributors, hospital dispensaries, independent pharmacies, and other retail outlets to ensure that they comply with prevailing regulations and guidelines.

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